Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Shandong University200 enrolled

Overview

Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

200

Conditions

Dyspepsia

Interventions

pCLE examinationDEVICE

All FD patients received pCLE examination.

PuyuanheweiDRUG

FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Consecutive outpatients aged 18 to 75 years old. 2. FD patients defined by the Rome III classification. 3. Willing to choose pCLE and no organic diseases. Exclusion Criteria: 1. Severe liver, heart, or kidney diseases. 2. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse. 3. Pregnant or breastfeeding women. 4. Inability to give informed consent. 5. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

pCLE score

Used to assess the gastric barrier dysfunction of FD patients

Time frame: within 1 hour after pCLE examination

Secondary Outcomes

Leeds dyspepsia questionaire

Used to describe the change of severity of FD from baseline to the 4th week during the treatment

Time frame: baseline and 4th week

Main dyspepsia symptom score

Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment

Time frame: baseline and 4th weeks

Central Contacts

Yanqing Li, MD.PhD.

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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